Clinical Trial: Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Placebo-controlled, "Factorial" Design, 12-month Study to Evaluate the Efficacy and Safety of AVE5530 25 mg/Day and 50 mg/Day Co-administered With All Registered A

Brief Summary: The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

Detailed Summary: The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.
Sponsor: Sanofi

Current Primary Outcome: Percent change from baseline in calculated LDL-C [ Time Frame: At week 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change from baseline in calculated LDL-C [ Time Frame: At 6 months and 12 months ]
  • Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP [ Time Frame: At week 12, 6 months and 12 months ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: August 25, 2008
Date Started: August 2008
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016